Athletic Performance, Muscle Fatigue, Recovery of Function (G11.427.698.620), Sleep Quality, Sport
Conditions
Keywords
Heart Rate Variability, Soccer, Amino Acids, Body Composition, Garmin Wearables, DEXA, Post-Exercise Recovery
Brief summary
The purpose of this study is to evaluate the effects of KA-EX supplementation on recovery parameters in elite young football players. Athletes from the Udine Primavera team will be randomly assigned to receive either the KA-EX supplement or a sensory-matched placebo immediately following their training sessions for a period of two months. The researchers will monitor heart rate variability (HRV) and sleep quality using Garmin wearable devices, and assess changes in body composition using Dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA). The goal of the study is to determine if post-training KA-EX administration improves physiological recovery, sleep quality, and physical readiness in high-performance athletes during a competitive season.
Detailed description
Background and Rationale: Post-exercise recovery is a critical determinant of performance and adaptation in high-level football players. Insufficient recovery can lead to decreased physical readiness and increased risk of injury. KA-EX is a nutritional supplement containing a complex of amino acids, electrolytes, and functional sugars designed to support metabolic and physiological recovery. This study aims to investigate its efficacy in a real-world elite training environment. Study Objectives: The primary objective is to evaluate the effect of KA-EX supplementation on physiological recovery parameters (HRV). Secondary objectives include assessing the impact on sleep recovery indices, changes in body composition (via DEXA), and cellular health parameters (via BIA). Methodology and Design: This is an experimental, randomized, double-blind, placebo-controlled study. Participants: 25 male players from the Udine Primavera team (Italy). Intervention: Participants will be randomly assigned to an experimental group (KA-EX) or a control group (placebo). The products will be identical in appearance, taste, and packaging to ensure blinding. Duration: The intervention will last for 2 months, typically following the pre-season period. Procedures: Baseline Assessment: Participants will undergo initial DEXA scans, bioelectrical impedance analysis (BIA 101), and anthropometric measurements. Monitoring with Garmin devices will be initiated. Intervention Phase: Supplements or placebos will be administered immediately after every training session. Recovery variables (HRV and sleep) will be continuously monitored using Garmin algorithms. Final Assessment: At the end of the 2-month period, DEXA, BIA, and anthropometric measurements will be repeated to evaluate longitudinal changes. Statistical Analysis: Within-group and between-group differences will be analyzed to compare the magnitude of change from baseline to post-intervention. Temporal evolution of recovery metrics throughout the 8-week period will also be assessed.
Interventions
DIETARY_SUPPLEMENTKA-EX
Powder sachet to be dissolved in water. Contains a patented complex of amino acids, electrolytes, and carbohydrates designed to normalize cortisol and support recovery.
DIETARY_SUPPLEMENTExperimental: KA-EX Supplement
Powder sachet with identical organoleptic characteristics but without the active recovery ingredients of KA-EX.
Sponsors
Antonio Molina Lopez
Universidad Europea de Madrid
University of Udine
Universidad Pablo de Olavide
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Both KA-EX and Placebo are provided in sensory-matched packaging (same taste, texture, and appearance) to ensure neither the athletes nor the researchers collecting Garmin and BIA data know the allocation
Intervention model description
Participants are randomly assigned to one of two groups (KA-EX or Placebo) for the entire 2-month duration of the intervention to compare between-group differences in recovery parameters.
Eligibility
Sex/Gender
MALE
Age
17 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* Membership of the Udine Primavera team at the time of the study. Regular participation in the training programme during the intervention period (September). Provision of written informed consent to participate in the study. Willingness to use a Garmin wearable device for continuous monitoring of recovery variables.
Exclusion criteria
* Presence of any injury or medical condition that limits normal participation in team training sessions. Use of any other recovery supplements or ergogenic aids outside of the study protocol during the intervention period. Failure to comply with the daily supplementation protocol or the scheduled assessment sessions (DEXA/BIA).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Heart Rate Variability (rMSSD) | Baseline and daily for 8 weeks. | Autonomic recovery assessed as Root Mean Square of Successive Differences (rMSSD) during nocturnal sleep via Garmin wearable devices. Higher values indicate better parasympathetic recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Sleep Score | Daily for 8 weeks. | Overall sleep quality score calculated by Garmin's proprietary algorithm based on sleep duration, REM, and deep sleep cycles. |
| Change from Baseline in Recovery Readiness Index | Daily for 8 weeks. | Daily readiness score (Body Battery) obtained via Garmin wearable algorithm. Scores range from 0 to 100; higher scores indicate greater physical readiness for training. |
| Body Composition | 8 weeks. | Body composition assessed at week 8. Lower values indicate reduction |
Countries
Italy
Contacts
CONTACTFrancisco J. Berral de la Rosa, PhD
Outcome results
None listed